FDA Regulation of Cosmetics

EAS Consulting Group, LLC assists cosmetic companies with a variety of FDA regulatory requirements. From working with FDA on approval of color additive petitions used in cosmetics, to an assessment of a manufacturer’s or packers Good Manufacturing Practices, to Voluntary Registration of facilities to labeling and claims including website information, our expert cosmetics consultants can assist your company in maintaining FDA compliance.

EAS can also arrange and/or attend meetings with FDA agency officials on behalf of your company as well as interpret rulings and policies as they relate to your products or practices. EAS can provide regulatory updates and advice for current practices and policy developments.

Below is additional information on areas in which EAS can help:

Ingredient Premarket Approval and Color Additive Petitions:

With the exception of color additives, cosmetic products and ingredients do not needs FDA premarket approval. Relying on the publically available safety data from toxicology testing of in individual ingredients and product formulations that are similar in composition to the particular cosmetic, FDA feels the safety of cosmetic products can be assured.

However, there are several cosmetic product ingredients that do require warning statements on product labels or are restricted from use entirely. Those products which include such ingredients are considered to be adulterated, or which do not include proper labeling are considered to be misbranded.

EAS can work with your company to prepare and submit color additive petitions for FDA certification as well as compile toxicology reports and studies to determine ingredient safety, or design clinical studies to document ingredient safety and substantiate label claims. Our expert label consultants can also review and design labels for FDA compliance, preventing misbranding.

Good Manufacturing Practices:

FDA has not issued formal Good Manufacturing Practices for cosmetics, however they have issued informal guidance and also recommend possible use of the ISO GMP standards for cosmetics. Products that are both cosmetics and drugs must follow rigorous GMP requirements. Failure to follow those GMP requirements as listed for drugs [Title 21 of the Code of Federal Regulations (CFR), parts 210 and 211] can cause your product the classified as adultered and subject to seizure by FDA.

Cosmetic manufacturers can expect FDA to inspect their facilities to assure product safety compliance with GMPs as well as to determine whether a product is adulterated or misbranded.

EAS consultants can assist with GMP audits and mock FDA inspections to help your company identify areas of strength and weakness. We can also formulate an action plan for your company to help strengthen needed areas, bringing your company’s GMPs into FDA compliance.

Product and Formulation Registrations:

Cosmetic product registration is not required under FDA law, nor is a registration number required to import cosmetic products into the U.S. However, cosmetic manufacturers, distributors and packers are encouraged to voluntarily participate in FDA’s Voluntary Cosmetic Registration Program (VCRP) online registration system and list their manufacturing and/or holding facility locations.

Also, FDA does not require manufacturers to file their cosmetic product formulations.

While EAS cannot complete your voluntary registration because it must be completed by the manufacturer, we can assist in registration and answer any questions related to registration and the completion of the on-line forms.

Cosmetic Labeling Regulations:

Cosmetics must be labeled in accordance with cosmetic marketing regulations set forth in FDA’s Cosmetic Labeling Manual. Claims about what a product can do or how it impacts the body should have scientific backing. Cosmetic product labeling can be complicated and confusing and we can help you develop labels that comply with all regulations and promote your product effectively.

Those products which are considered combination cosmetic/OTC drugs must use the combination OTC drug/cosmetic labeling requirements, which include an alphabetical listing of drug ingredients listed as “active ingredients, followed by cosmetic ingredients, or “inactive ingredients” which should be listed in descending order of predominance.

A product recall can be one of the most upsetting and frustrating occurrences for a business. After all the time, effort and expense in getting a product to market, when a recall is necessary, the additional required time, effort and expenses can be exponential.

FDA is not authorized to require a recall of cosmetic products, however they may request companies to do so. And sometimes a recall is the best course of action for you to avoid possible consumer injuries. In general, the cosmetic company itself initiates a voluntary recall. A recall may require removing the product from the marketplace entirely or taking corrective actions to fix the problem.

In the unfortunate event of a recall, EAS can quickly and thoroughly assist in formulating an action plan to remove and correct the situation which warranted FDA’s attention. Assisting your company in bringing your products back to the U.S. marketplace in a manner that meets FDA’s requirements is our priority.

US Agent Services:

Foreign color manufacturers are required to have a U.S. Agent which acts as a conduit between FDA and the foreign company. EAS serves as the U.S. Agent for a number of foreign color manufacturers.